1. Field of the Invention
The device of this invention resides in the area of sutures and fasteners for closing the two sides of an incision or cut in human skin or other body tissue and more particularly relates to a suture having adhesive thereon cured by external activation, such suture having an elongated body member with body tissue adhesive thereon which body member is inserted or drawn laterally through a cut to join the two sides of the cut together at which time the adhesive is activated by high-frequency radiation to cause the adhesive to set.
2. Description of the Prior Art
Sutures for closing incisions or wounds are well known in the prior art. Such sutures or ligatures are often attached to the shank end of a needle and are utilized by physicians to make stitches to close incisions or wounds so that they may heal. Frequently such sutures can cause the skin to bunch up in areas where they are tied around the skin rather than bringing the sides of the cut tissue together in neat, parallel alignment. Sutures are formed not only of threadlike material, but are also available as a one-piece unit combined with a needle. Sutures are available in a wide variety of monofilament and braided suture material. Sutures can be formed of non-absorbable material such as cat gut, silk, nylon, polyester, polypropylene, linen, or cotton as well as bioabsorbable synthetic material such as polymers and copolymers of glycolic and lactic acid. Germicides can also be incorporated into the structure of the suture which can be retained by the suture substrate to provide long-lasting germicidal properties.
Also known in the prior art are fasteners which eliminate the need for sutures in many instances. These fasteners are commonly referred to as xe2x80x9cstaplesxe2x80x9d and are useful in joining tissue layers laterally, for example, closing wounds in skin or fascia. Such staples are dispensed by implanting devices loaded with such surgical fasteners, the use of which devices can accomplish in very short time what would take many minutes to perform by suturing. Some staples can be made of bioabsorbable materials. The use of such fasteners results in a significant reduction in blood loss and also lowers the level of trauma to the patient. Such staples can be in the form of metal staples which have arms bent by the fastening device to hook the separated body tissue together. Staples can require the stapling apparatus to have an anvil member which must be positioned under the tissue to be stapled so that the arms of the staple can be bent inwards. Two-part fastening devices also have been used which incorporate a barbed staple, the arms of which are attached to a bottom retainer member. In some cases a drawback to employing staples is that a retainer member must be attached under the body tissue to be joined, and one must have access to the body tissue both from above and below the body tissue. Metal staples applied to the body must also be removed by staple extractors.
Other types of surgical fasteners include skin tacks which are used to join two sides of an incision. Such skin tacks include a barbed tip on each end of the inverted U-shaped tack, the body of which is transversely positioned across an incision or cut and the tack is applied so that the barbed tips engage straight downward into the skin to hold each side of the adjacent layers of body tissue together. More recently xe2x80x9czippersxe2x80x9d have been applied on each side of an incision which allow for reopening, if desired.
The Applicant herein has patented a suture assembly having a central body member with a plurality of elongated lateral members extending from the central body member from each side thereof, each such lateral member having a plurality of barbs thereon to retain the lateral members securely in the body tissue, as described in U.S. Pat. No. 5,425,747. The Applicant further developed a method of lateral member insertion utilizing shaft-like, removable insertion members which can push each lateral member into position in the tissue and which insertion member can then be removed, as described in Applicant""s U.S. Pat. No. 5,584,859. The Applicant also has a pending application Ser. No. 09/498,308 filed Feb. 4, 2000 for a single suture with adhesive thereon which is activatable when drawn into body tissue.
It is an object of this invention to provide an improved surgical fastener and method for joining skin or other body tissue together such as when separated by a cut or an incision.
The structure of this invention in one embodiment consists of a suture assembly having an elongated body member with first and second ends and having a needle member disposed at one end thereof, a stop member at the other end thereof, and adhesive disposed along the body member. In use one would insert the needle member on the surface of the skin at an entry point adjacent to the cut to be closed on the first side of the cut and draw the suture material, such as a thread member, through the body tissue and out through the first inside of the cut and then into the second inside of the cut and then up through the body tissue of the second side and out an exit point on the surface of the second side of the cut. One would draw the needle member and attached suture/thread member, pulling the suture carrying the adhesive into the body tissue such that the suture is positioned within both sides of the cut. When used, a stop member prevents pulling the suture too far when the suture is stopped from further movement by the stop member""s contact with the surface of the skin. One then pulls the sides of the cut together and then activates the adhesive from the exterior of the skin by applying high-frequency radiation onto the skin which radiation passes through the skin and activates and sets the adhesive, thereby retaining the body tissue to the suture and holding the sides of the cut together. The end of the thread member can be cut off once the suture has brought the two sides of the cut together and the suture has been fixed in position by application of high-frequency radiation to set the adhesive. Other types of single sutures can be used such as a suture having a rigid portion for insertion into one side of the cut and a flexible portion which is easily manipulable and pulled by the needle and thread into the other side of the cut after which the cut is closed around the suture and the adhesive on the suture is externally activated, as described above. In some embodiments the suture can include barbs, as described in my prior art inventions, to aid in retaining the body tissue therearound as the suture is positioned for the adhesive to be externally activated. Such improved fastener and joining method can also be used for the fixation of internal tissues such as knee lateral displacement corrections, ligament reattachment operations and the like where an externally activatable and curable adhesive coating on such suture can act as a procedural aid to temporarily hold tissues in tension while the surgeon is performing other acts. The use of the suture of this invention can also be helpful in dental and facial surgery as it eliminates annoying suture knots.
It should be noted that an adhesive can be utilized which, when one frequency of high-frequency radiation is externally applied, will be activated and cured; and when a different frequency radiation is applied to the cured adhesive, will be deactivated, turning the adhesive to a liquid state so that the suture is released from its hold in the tissue. Such liquid adhesive is absorbed by the body. This activation and deactivation of the adhesive is particularly well suited when using temporary suturing as it allows for the reopening of an incision when further work is needed to be done.